Cellectar Biosciences (CLRB) Announces Positive Data from Second Cohort of CLR 131 Phase 1 in r/r Multiple Myeloma

September 29, 2016 8:35 AM EDT

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Cellectar Biosciences, Inc. (Nasdaq: CLRB) announces positive data from the second cohort of patients enrolled in its orphan-drug designated Phase I study of CLR 131 in patients with relapsed or refractory multiple myeloma. Following these outcomes, the study’s Data Monitoring Committee approved patient enrollment to the third cohort, which will include a 33 percent dose increase from 18.75 to 25mCi/m2 of CLR 131 from the previous cohort.

All evaluable study participants (n=8) have achieved stable disease and progression-free survival (PFS), which includes four evaluable patients from Cohort 1 and four evaluable patients from Cohort 2. To date, Cohort 2 subjects have attained an average increase in PFS of greater than 30 percent as compared to Cohort 1. Cellectar continues to follow patient outcomes within Cohort 2, including PFS. After these patients have fully completed the study, the company looks forward to providing additional study data, including the full extent of the increase in PFS from Cohort 2 over Cohort 1. While patients in Cohort 2 received a 50 percent increase in dose, they did not experience a proportional increase in adverse events and demonstrated a similarly favorable safety and tolerability profile as experienced by patients in Cohort 1.

“As seen in the results to date, CLR 131 has demonstrated an outstanding safety profile in heavily pretreated, relapsed or refractory multiple myeloma patients with limited treatment options,” stated Natalie Callander, MD, Associate Professor of Medicine, Director, University of Wisconsin Carbone Cancer Center Myeloma Clinical Program, and the study’s lead investigator. “I am excited that Cellectar will open the next treatment cohort to offer patients access to this novel treatment’s encouraging efficacy signals.”

In this multi-center, open label Phase I dose escalation study, CLR 131 is administered as a single dose, 30-minute infusion. The primary study objective is to characterize the safety and tolerability of CLR 131 in patients with relapsed or refractory multiple myeloma. Prior to enrollment, all study participants had received a minimum of three systemic regimens and up to 12 lines of therapy. Many also received a stem cell transplant. Secondary study objectives include establishment of a recommended Phase II dose, both with and without dexamethasone, as well as an assessment of therapeutic activity.

“This important clinical milestone further validates the potential of our patented PDC delivery platform as well as the clinical benefits of CLR 131 for the treatment of an extremely challenging hematologic cancer,” said Jim Caruso, president and CEO of Cellectar Biosciences. “We are focused on successfully executing this Phase I Study for relapsed or refractory multiple myeloma, as well as initiating our National Cancer Institute-supported Phase II study to further explore dose, regimen and clinical utility of CLR 131 in multiple myeloma and other selected hematologic malignancies with unmet medical need.”

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